Aromatherapy – Essential oils Page 1 of 14
NATURAL HEALTH PRODUCT
AROMATHERAPY – ESSENTIAL OILS
This monograph is intended to serve as a guide to industry for the preparation of Product Licence
Applications (PLAs) and labels for natural health product market authorization. It is not intended
to be a comprehensive review of the medicinal ingredients.
Notes Text in parentheses is additional optional information which can be included on the PLA
and product label at the applicant’s discretion.
The solidus (/) indicates that the terms and/or the statements are synonymous. Either term
or statement may be selected by the applicant.
All claims must include the qualifier “Used in aromatherapy”.
Date December 8, 2015
Medicinal Ingredients
Refer to Appendix 1
Proper name(s), Common name(s), Source material(s), Dose(s)
Refer to Appendix 1
Route(s) of administration
Topical
Inhalation
Dosage form(s)
Those dosage forms suited for inhalation and/or topical administration including but not limited
to liquids, oils, sprays, roll-ons.
Use(s) or Purpose(s) Statement(s) to the effect of
Refer to last column of Appendix 1 for uses supported for each medicinal ingredient.
1. Used in aromatherapy for symptomatic relief of acne/boils.
Aromatherapy – Essential oils Page 2 of 14
2. Used in aromatherapy to relieve minor skin irritation/cuts/bruises/burns.
3. Used in aromatherapy for symptomatic relief of eczema/dermatitis.
4. Used in aromatherapy as a nervine/calmative.
5. Used in aromatherapy to help relieve joint/muscle pain associated with
sprain/strain/rheumatoid arthritis.
6. Used in aromatherapy to help relieve headache.
7. Used in aromatherapy as a carminative/antispasmodic for symptomatic relief of digestive
discomfort.
8. Used in aromatherapy to help relieve colds/cough.
Notes Uses # 1, 2, 3 and 5 are for topical route of administration only.
Uses # 4, 6, 7 and 8 are for topical and/or inhalation route of administration.
Dose(s)
Subpopulation(s)
Adults (≥ 18 years)
Quantity(ies)
Refer to Appendix 1 and/or Directions for use section below.
Ingredient Combinations
All ingredients included in this monograph may be combined together with the following
restrictions:
For local topical application/body massage, the total concentration of the combined
essential oils must not exceed 5%; and
Each essential oil in the product combination must not exceed its maximum concentrations
listed in Appendix 1.
Directions for use Statement(s) to the effect of
All products
Not for oral use.
Avoid contact with eyes and mucous membranes; if this happens, rinse thoroughly with
vegetable oil.
Aromatherapy – Essential oils Page 3 of 14
Local application (10% or less of body surface area)
Apply to affected area up to 3 times per day.
Body massage (more than 10% of the body surface area)
Apply once daily.
Essential oils requiring dilution (topical)
Do not use essential oils undiluted.
Note:
Directions of use explaining appropriate dilution of essential oils in carrier oil must be included
on the PLA form and label (refer to Appendix 2).
Sprays used for muscle pain/other topical use
Rub and/or massage into skin until solution vanishes.
Bath
Add 2 – 8 drops of undiluted essential oil with the same amount of shampoo or liquid soap
before adding it to the bath. Mix the water gently. For maximum benefit, remain in the bath
for 10 minutes. Use 2 drops of undiluted essential oil the first time and increase by 1 drop
per bath up to a maximum of 8 drops (Tisserand 1977; Price and Price 2007).
Use once daily.
Direct inhalation
Apply 1 – 6 drops of undiluted essential oil to a handkerchief/tissue and inhale occasionally
(Price and Price 2007).
Up to 3 times per day.
Steam inhalation
Add 3 – 12 drops of undiluted essential oil to a bowl of steaming water/facial steamer.
Inhale slowly and deeply for 5 to 10 minutes (Price and Price 1999; Tisserand and Balacs
1995).
Up to 3 times per day.
Compresses
Aromatherapy – Essential oils Page 4 of 14
Add 2 drops of undiluted essential oil to 500 ml of warm water in a bottle. Mix by shaking
the bottle and immediately soak the compress . Squeeze lightly, apply the compress to the
skin, and cover with clothes and/or towelling. Leave for 2 to 4 hours (Tisserand 1977).
Up to 3 times per day.
Notes:
A drop size of 0.05 ml is used for this monograph; however, drop size may vary (refer to
Appendix 2).
Number of drops indicated above should be adjusted for pre-diluted essential oil.
Duration of use Statement(s) to the effect of
All products
For occasional use only.
Risk information Statement(s) to the effect of
All products Caution(s) and warning(s):
Keep out of reach of children.
If accidental ingestion occurs, seek urgent medical attention or contact a Poison
Control Center.
If symptoms persist or worsen, consult a health care practitioner.
If you have epilepsy or asthma, consult a health care practitioner prior to use
(Tisserand and Young 2014).
Contraindication(s):
If you are pregnant or breastfeeding, do not use this product.
Known adverse reaction(s):
If you experience nausea, dizziness, headache or an allergic reaction, discontinue
use (Tisserand and Young 2014).
Products
for local
application/
body
massage
Caution(s) and warning(s):
All products (except products that contain phototoxic essential oils; refer to
Appendix 1)
Avoid exposure of applied area(s) to the sun.
Products that contain phototoxic essential oils (refer to Appendix 1)
Do not expose the applied area(s) to the sun for 24 to 48 hours after application
(Kumar et al. 1992).
Contraindication(s):
Products that contain sensitizing essential oils (refer to Appendix 1)
If you have broken, irritated, or sensitive skin, do not use this product.
Aromatherapy – Essential oils Page 5 of 14
Storage conditions
All products
Child-resistant packaging/containers should be used (JC 2012).
Store in airtight, light-resistant container at room temperature
Non-medicinal ingredients
Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and
must meet the limitations outlined in the database.
Specifications
The finished product specifications must be established in accordance with the
requirements described in the Natural and Non-Prescription Health Products Directorate
Quality of Natural Health Products Guide.
The medicinal ingredient must comply with the requirements outlined in the NHPID.
References cited
AHPA 2012: American Herbal Products Association Guidance Policies: Trade Requirement &
Guidance Policy for Labeling of Undiluted Essential Oils Used Topically and Offered for Retail
Sale, [Accessed 2014 July 14]. Available from:
http://www.ahpa.org/Default.aspx?tabid=223#section_essentialoils
Davis P. Aromatherapy An A-Z. Saffron Walden, (GB): The C.W. Daniel Company Limited;
1997.
HC 2013: Health Canada, Natural Health Product Ingredients Database: Counterirritants.
[Published 2013 July 3]. Available from: http://webprod.hc-sc.gc.ca/nhpid-
bdipsn/atReq.do?atid=counter&lang=eng
JC 2012: Justice Canada. Cautionary Statements and Child Resistant Packages. Sections
C.01.001 (2) to (4) and C.01.029, C.01.031 and C.01.031.2 (1). Ottawa (ON): Department of
Justice Canada. [Accessed 2013 December 10]. Available from: http://laws-
lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/page-
205.html?texthighlight=statements+cautionary+resistant+packages+child
Kumar JR, Ranadive NS, Menon A, Haberman HF. Photoinduced cutaneous inflammatory
response by psoralens. Journal of Photochemistry and Photobiology 1992;14(1-2):125-137.
Aromatherapy – Essential oils Page 6 of 14
Lis-Balchin M. Aromatherapy Science: A guide for healthcare professionals. London (GB):
Pharmaceutical Press; 2006.
Price S, Price L. Aromatherapy for Health Professionals, 3rd edition. Edinburgh (GB): Churchill
Livingstone; 2007.
Tisserand RB. The Art of Aromatherapy: The healing and beautifying properties of the essential
oils of flowers and herbs. Rochester (VT): Healing Arts Press; 1977.
Tisserand R, Young R. Essential oil safety: A guide for health care professionals, 2nd edition.
Edinburgh (GB): Churchill Livingstone; 2014.
Valnet J. Aromathérapie, 11th edition. Paris (F): Vigot; 2001.
References reviewed
Battaglia, S. The Complete Guide to Aromatherapy. Brisbane (AU): The Perfect Potion; 1995.
Battaglia, S. The Complete Guide to Aromatherapy, 2nd
ed. Brisbane (AU): The International
Centre of Holistic Aromatherapy; 2004.
British Pharmacopoeia Commission. British pharmacopoeia 2013. (Vols. IV and V) London
(GB): The Stationary Office; 2012.
Carson CF, Hammer KA, Riley TV. Melaleuca alternifolia (tea tree) oil: A review of
antimicrobial and other medicinal properties. Clinical Microbiology Reviews 2006;19(1):50-62.
Council of Europe. European pharmacopeia. (Vol. 1). Strasbourg, France: Directorate for the
Quality of Medicines & Health Care; 2010.
Price S, Price L. Aromatherapy for Health Professionals, 2nd edition. Edinburgh (GB): Churchill
Livingstone; 1999.
Price S, Price L. Aromatherapy for Health Professionals, 4th edition. Edinburgh (GB): Churchill
Livingstone; 2012.
Tisserand R, Balacs T. Essential oil safety: A guide for health care professionals. Edinburgh
(GB): Churchill Livingstone; 1995.
United States Pharmacopeial Convention. The United States pharmacopeia – national formulary.
Baltimore (MD): United Book Press; 2013.
USDA 2014. National Genetic Resources Program. Germplasm Resources Information Network
- (GRIN) [Internet]. National Germplasm Resources Laboratory, Beltsville, Maryland. Available
from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
Aromatherapy – Essential oils Page 7 of 14
Worwood VA. The complete book of essential oils and aromatherapy. Novato (CA): New World
Library; 1991.
Aromatherapy – Essential oils Page 8 of 14
Appendix 1
Notes:
All medicinal ingredients in Table 1 are steam distilled, unless otherwise stated.
See Appendix 3 for definitions of various preparations (i.e. steam distilled, expressed,
preparation of an absolute, rectified).
The concentrations in Table 1 refer to final concentrations after dilution to be applied on
the skin.
The quantity per dosage unit for undiluted (pure) essential oils should be indicated as “100
%” on the P LA form with appropriate dilution information (such as mixing XX drops of
essential oil in YY mL of carrier oil) in the Directions for use section.
Table 1: Medicinal ingredientsa
Proper name(s)
(S) Sensitizingb
(P) Phototoxicc
Common name(s)
Source
material(s)
Concentration for
Topical application:
Min. – Max. massage
(Max. local)%d
Acceptable
Use(s)e
Abies balsamea Balsam fir essential oil
Balsam essential oil
Needle
Twig 1 – 5(10)% 4, 5
Abies sibirica Siberian fir essential oil Needle
Twig 1 – 2.5% 5, 8
Angelica
archangelica
(S, P)
Angelica essential oil Root
Seed 0.78% 4, 5, 6, 7, 8
Aniba rosaeodora Rosewood essential oil Wood 1 – 5(10)% 1, 2, 4, 6, 8
Apium graveolens
(P) Celery essential oil Seed 1 – 4% 4, 5
Boswellia frereana
Frankincense essential oil
Olibanum essential oil Stem resin
1 – 5(8)% 2, 4, 8
Frankincense absolute
Olibanum absolute 1 – 3% (absolute) 2, 4, 8
Boswellia sacra
Frankincense essential oil
Olibanum essential oil Stem resin
1 – 5(8)% 2, 4, 8
Frankincense absolute
Olibanum absolute 1 – 3% (absolute) 2, 4, 8
Cananga odorata
(S)
Cananga essential oil
Ylang ylang essential oil Flower 1 – 2% 4
Carum carvi Caraway essential oil Fruit
Seed 1 – 4% 7, 8
Cedrus atlantica
(P)
Atlas Cedarwood essential
oil
Cedarwood essential oil
Wood 1 – 5(8)% 1, 2, 4, 5, 8
Chamaemelum nobile
Roman chamomile essential
oil
English chamomile essential
oil
Herb top
flowering 1 – 4% 4, 7
Aromatherapy – Essential oils Page 9 of 14
Proper name(s)
(S) Sensitizingb
(P) Phototoxicc
Common name(s)
Source
material(s)
Concentration for
Topical application:
Min. – Max. massage
(Max. local)%d
Acceptable
Use(s)e
Chrysopogon
zizanioides Vetiver essential oil Root 1 – 1.5% 1, 5
Cinnamomum
camphora White camphor essential oil
Stem Bark
Wood
Branch
1 – 5(20)% 1, 2, 5, 8
Cinnamomum verum
(S) Cinnamon essential oil
Leaf
Twig 1 – 5(10)% 5, 8
Cistus ladanifer Labdanum essential oil Gum 1 – 5(8)% 4, 5, 7
Citrus aurantiifolia
(P) Expressed Lime essential oil
Unripe fruit
peel
0.7%
(expressed) 1, 5, 8
Ripe fruit
peel 1 – 5(15)%
Citrus aurantium
(S, P)
Neroli essential oil
Bitter orange essential oil Flower
1 – 4% 4, 6, 7, 8
Neroli absolute
Bitter orange absolute 1 – 3% (absolute)
Petitgrain essential oil Leaf 1 – 5(10)% 4, 5
Citrus bergamia
(P)
Bergamot (FCF) essential oil
FCF = Furanocoumarin-free Fruit peel
1 – 5(20)%
(expressed–rectified) 1, 2, 3, 6, 7, 8
Bergamot essential oil 0.4%
(expressed) Citrus paradisi
(P) Grapefruit essential oil Fruit peel
1 – 4%
(expressed) 4
Citrus limon
(S, P) Expressed Lemon essential oil Fruit peel
1– 2%
(expressed) 8
1– 5(10)%
Citrus sinensis
(S, P)
Sweet orange essential oil
Orange essential oil Fruit peel
1 – 5(10)%
(expressed) 4, 7
Commiphora myrrha
Myrrh essential oil
Sap Resin
1 – 5(8)% 2, 3, 8
Myrrh absolute 1 – 3%
(absolute) Corymbia citriodora
(S)
Lemon-scent gum essential oil
Citron-scent gum essential oil Leaf 1 – 5(20)% 5, 6, 8
Cuminum cyminum
(P) Cumin essential oil Seed 0.4% 4, 5, 7
Cupressus
sempervirens
Italian cypress essential oil
Mediterranean cypress
essential oil
Needle
Twig 1 – 4% 5, 8
Cymbopogon citratus
(S) Lemongrass essential oil Herb top 1 – 4% 4, 5, 6, 7
Cymbopogon
flexuosus (S)
East Indian lemongrass essential
oil Herb top 1 – 4% 4, 5, 6, 7
Cymbopogon martini
(S) Palmarosa essential oil Herb top 1 – 5(8)% 4, 8
Aromatherapy – Essential oils Page 10 of 14
Proper name(s)
(S) Sensitizingb
(P) Phototoxicc
Common name(s)
Source
material(s)
Concentration for
Topical application:
Min. – Max. massage
(Max. local)%d
Acceptable
Use(s)e
Cymbopogon nardus
(S)
Citronella essential oil
Ceylon citronella essential oil Herb top 1% 5, 6, 7
Cymbopogon
winterianus
(S)
Burma citronella essential oil
Java citronella essential oil Herb top 1% 5, 6, 7
Elettaria
cardamomum Cardamom essential oil Seed 1 – 4% 7, 8
Eucalyptus globulus
(S) Eucalyptus essential oil Leaf 1 – 5(25)% 5, 6, 8
Eucalyptus
polybractea
(S)
Blue mallee essential oil Leaf 1 – 5(20)% 5, 6, 8
Eucalyptus radiata
(S)
Narrow-leaf peppermint
essential oil Leaf 1 – 5(20)% 5, 6, 8
Foeniculum vulgare
subsp. vulgare var.
vulgare
Bitter fennel essential oil Seed 1 – 4% 2, 5, 7, 8
Foeniculum vulgare
subsp. vulgare var.
dulce
Sweet fennel essential oil
Roman fennel essential oil Seed 1 – 4% 2, 5, 7, 8
Helichrysum italicum
Immortelle essential oil
Curry plant essential oil
Herb top
flowering 0.5%
1, 2, 3, 4, 5, 7,
8
Illicium verum
(S) Star anise essential oil Fruit 1 – 2% 4, 5, 6, 7, 8
Jasminum officinale
(S) Jasmine absolute Flower
0.7%
(absolute) 4, 5, 6, 8
Juniperus communis
Juniper essential oil
Common juniper essential
oil
Fruit 1 – 5(8)% 1, 2, 3, 4, 5
Laurus nobilis
(S)
Bay laurel essential oil
Laurel essential oil
Leaf
Twig 1 – 2% 4, 5, 6, 8
Lavandula
angustifolia
(S, P)
Lavender essential oil Herb top
flowering 1 – 5(15)% 4, 5, 6, 7, 8
Lavandula x
intermedia
(S, P)
Lavandin essential oil Herb top
flowering 1 – 5% 4, 5, 6, 7, 8
Lavandula latifolia
(S, P)
Spike lavender essential oil
Herb top
flowering 1 – 5(8)% 4, 5, 6, 7, 8
Litsea cubeba
(S) Litsea essential oil Fruit 1 – 5(8)% 7
Matricaria
chamomilla
Chamomile essential oil
German chamomile essential
Herb top
flowering 1 – 4% 1, 2, 4, 5, 6, 7
Aromatherapy – Essential oils Page 11 of 14
Proper name(s)
(S) Sensitizingb
(P) Phototoxicc
Common name(s)
Source
material(s)
Concentration for
Topical application:
Min. – Max. massage
(Max. local)%d
Acceptable
Use(s)e
oil
Melaleuca
alternifolia
(S)
Tea tree essential oil Leaf
Twig 1% 8
Melaleuca cajuputi Cajuput essential oil Leaf 1 – 4% 1, 3, 5, 8
Melissa officinalis
(S) Lemon balm essential oil Leaf 0.7% 4, 7
Mentha arvensis Cornmint essential oil Twig
flowering 1 – 5(8)% 1, 4, 5, 7, 8
Mentha x piperita
(S) Peppermint essential oil
Twig
flowering 1 – 5(8)% 4, 5, 7, 8
Mentha spicata
(S) Spearmint essential oil
Twig
flowering 1 – 4% 4, 6, 7, 8
Myristica fragrans Nutmeg essential oil Seed 1 – 2% 4, 5, 7
Myrtus communis Myrtle essential oil Leaf
Twig 1 – 4% 1, 8
Ocimum basilicum
(S) Sweet basil essential oil
Herb top
flowering 1 – 4% 4, 6, 7, 8
Origanum majorana Sweet marjoram essential oil
Marjoram essential oil
Herb top
flowering 1 – 4%
2, 3, 4, 5, 6, 7,
8
Pelargonium
graveolens
(S)
Rose geranium essential oil
Geranium essential oil
Leaf
Herb top
flowering
1 – 5(10)% 8
Petroselinum crispum
(P) Parsley essential oil
Herb top
Seed 1 – 2% 2, 4, 5
Pinus sylvestris
(S) Scotch pine essential oil Needle 1 – 5(10)% 4, 5, 8
Piper cubeba Cubeb essential oil Seed 1 – 5(8)% 2, 7, 8
Piper nigrum Black pepper essential oil Fruit 1 – 4% 5, 6, 7, 8
Pogostemon cablin Patchouli essential oil Leaf 1 – 5(10)% 1, 2, 4, 7
Rosa x damascena Damask rose essential oil
Rose Essential Oil Flower 1 – 2% 2, 4, 6, 8
Rosa x centifolia Provence rose essential oil
Rose Essential Oil Flower 1 – 2% 2, 4, 6, 8
Rosmarinus
officinalis Rosemary essential oil
Herb top
flowering 1 – 5(6.5)% 2, 5, 7, 8
Salvia lavandulifolia Spanish sage essential oil Herb top
flowering 1 – 5(12.5)% 2, 4, 5, 7, 8
Aromatherapy – Essential oils Page 12 of 14
Proper name(s)
(S) Sensitizingb
(P) Phototoxicc
Common name(s)
Source
material(s)
Concentration for
Topical application:
Min. – Max. massage
(Max. local)%d
Acceptable
Use(s)e
Salvia officinalis Sage essential oil
Dalmation sage essential oil
Herb top
flowering 1 – 5(8)% 2, 4, 5, 7, 8
Salvia sclarea Clary essential oil
Clary sage essential oil
Herb top
flowering
Leaf
1 – 5(8)% 2, 4, 5, 6, 7, 8
Santalum album
(S)
Sandalwood essential oil
East Indian sandalwood
essential oil
Wood 1 – 5(10)% 4, 6, 7, 8
Satureja hortensis Summer savory essential oil
Savory essential oil Herb top 0.5 % 5, 7, 8
Styrax benzoin
(S) Benzoin essential oil Sap Resin 1 – 2% 4, 5, 7, 8
Syzygium aromaticum
(S) Bud, stem only Clove essential oil
Bud
Stem 1 – 4%
5, 8
Leaf 1 – 2%
Thymus vulgaris Thyme essential oil Herb top
flowering 1 – 5(8)% 1, 2, 4, 5, 8
Thymus zygis White Thyme essential oil Herb top
flowering 1 – 5(8)% 1, 2, 4, 5, 8
Zingiber officinale
(P) Ginger essential oil Rhizome 1 – 4% 5, 7, 8
a. The following references were consulted: Lis-Balchin 2006, Tisserand and Young 2014, Price and Price 1999, Davis
1997, Valnet 2001, HC 2013.
b. (S) – Sensitizing: For definition see Appendix 3. Additional duration of use and risk statements are required for
medicinal ingredients indicated as sensitizing (S). Refer to Risk information section.
c. (P) – Phototoxic: For definition see Appendix 3. Additional risk statements are required for all medicinal ingredients
indicated as phototoxic (P). Refer to Risk information section.
d. This section refers to minimum and maximum concentrations after dilution for body massage (covering more than
10% of body surface area). In cases where higher concentration is permitted for local applications (covering up to
10% of body surface area), information is included in brackets. e. Refer to Use(s)/purpose(s) section for recommended use associated with each number.
Aromatherapy – Essential oils Page 13 of 14
Appendix 2
Formula to calculate the number of drops of essential oil (EO) and the amount (in ml) of carrier
oil. (Refer to definition and examples of carrier oils in Appendix 3 to obtain the desired
concentration):
Number of drops of EO = Desired concentration of EO (%) * Volume of carrier oil (ml)
Volume of a drop (ml) * 100
Example:
If 1 drop = 0.05 ml:
To prepare a solution that contains 1% of essential oil, 4 drops of essential oil should be mixed
with 20 mL of carrier oil.
Directions for use: Mix 4 drops of essential oil in 20 ml of carrier oil.
Note: If your drop size is not 0.05 ml, adjust the number of drops accordingly.
Aromatherapy – Essential oils Page 14 of 14
Appendix 3
Definitions
Steam distilled: Natural raw material is placed in or above water in a retort and exposed to
steam, which carries the volatile oils into a condenser where the mixture is cooled. The oils
separate from the water and can be collected (AHPA 2012).
Expressed (cold-pressed): Used primarily to obtain citrus essential oils. The fruit is punctured
and then mechanically pressed. No external heat is applied during the extraction process (AHPA
2012).
Absolute: Product of solvent extraction. A solvent is used to extract the oils from the plant
material in which the product is called a “concrete” (mixture of essential oil, waxes, resins, and
other lipophilic (oil soluble) plant material). A more polar solvent is added to the concrete to
extract the essential oil. The alcohol is evaporated and leaves behind the absolute (AHPA 2012).
Rectified: Essential oil is purified by fractional distillation in order to remove unwanted
constituents (Tisserand and Young 2014).
Sensitizing: Sensitizing essential oils can cause sensitization reaction, also known as allergic
contact dermatitis, which is the usual clinical consequence of delayed hypersensitivity.
Sensitizing oils cause more pronounced effect on patients with rash, dermatitis, eczema, sensitive
skin and other skin conditions (Tisserand and Young 2014). These essential oils cause toxic
effect after multiple applications (Lis-Balchin 2006).
Phototoxic: Phototoxic essential oils produce burns, dermatitis, etc. (phototoxic effects) when
the treated skin area is exposed to direct sunlight. Phototoxic effects generally occur due to
inherent furanocoumarin content (Tisserand and Young 2014).
Carrier Oil: Carrier oil is fixed oil used to dilute essential oils and absolutes before they are
applied to the skin. Some of examples of carrier oils are Sweet almond oil, Grape seed oil,
Sunflower oil, Apricot kernel oil, and Peach kernel oil (Price and Price 2007).